An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
- Conditions
- CancerNon-small Cell Lung Cancer (NSCLC)
- Interventions
- Drug: Cofetuzumab Pelidotin
- Registration Number
- NCT04189614
- Lead Sponsor
- AbbVie
- Brief Summary
This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 65
- Histologically confirmed non-small cell lung cancer (NSCLC) with PTK7-expressing tumor using an immunohistochemistry (IHC) assay previously validated at a designated laboratory
- Recurrent NSCLC that has progressed after treatment with at least the following approved therapies with demonstrated clinical benefit: a platinum-based chemotherapy doublet and an immune checkpoint inhibitor for tumors without targetable genetic alterations; a platinum-based chemotherapy doublet and targeted agent(s) for tumors with targeted genetic alterations
- Received ≤ 2 prior lines of systemic therapy, including no more than 1 line of systemic cytotoxic chemotherapy (≤ 3 prior lines for tumors treated with targeted agent(s) for genetic alterations, including no more than 1 line of systemic chemotherapy)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Adequate bone marrow, renal, and hepatic function per the protocol
- Known uncontrolled metastases to the central nervous system (CNS). Participants with CNS metastases may be eligible provided that definitive therapy has been given, and participants are asymptomatic and off systemic steroids and anticonvulsants used for management of brain metastases for at least 2 weeks prior to the first dose of study drug
- Unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy (with the exception of alopecia or anemia)
- Has clinically significant medical condition(s) as described in the protocol
- Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days prior to the first dose of study drug (no washout period required for participants on EGFR tyrosine kinase inhibitors). Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period
- Received anti-cancer herbal therapies within 7 days prior to the first dose of study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cofetuzumab Pelidotin Cofetuzumab Pelidotin Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 3 years ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to approximately 3 years DOR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression or death from any cause.
Progression Free Survival (PFS) Up to approximately 3 years PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause.
Overall Survival (OS) Up to approximately 3 years OS is defined as the time from the participant's first dose of study drug until death from any cause.
Trial Locations
- Locations (26)
The Ohio State University /ID# 211088
🇺🇸Columbus, Ohio, United States
Stanford University School of Med /ID# 213450
🇺🇸Stanford, California, United States
Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 215102
🇪🇸Madrid, Spain
Sylvester Comprehensive Cancer Center /ID# 216433
🇺🇸Miami, Florida, United States
Oncology Consultants /ID# 215932
🇺🇸Houston, Texas, United States
Washington University-School of Medicine /ID# 213453
🇺🇸Saint Louis, Missouri, United States
Rambam Health Care Campus /ID# 217536
🇮🇱Haifa, H_efa, Israel
University of Texas MD Anderson Cancer Center /ID# 215876
🇺🇸Houston, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 216427
🇺🇸Fairfax, Virginia, United States
CHA Bundang Medical Center /ID# 232514
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
National Cancer Center Hospital /ID# 218536
🇯🇵Chuo-ku, Tokyo, Japan
Yonsei University Health System Severance Hospital /ID# 222281
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center /ID# 222280
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital Universitario Vall d'Hebron /ID# 215729
🇪🇸Barcelona, Spain
Samsung Medical Center /ID# 222906
🇰🇷Seoul, Korea, Republic of
University of Alabama at Birmingham - Main /ID# 213605
🇺🇸Birmingham, Alabama, United States
Univ of Colorado Cancer Center /ID# 215295
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center /ID# 215101
🇺🇸Tampa, Florida, United States
Rabin Medical Center /ID# 217537
🇮🇱Haifa, Israel
Tennessee Oncology, PLLC /ID# 215326
🇺🇸Nashville, Tennessee, United States
National Cancer Center Hospital East /ID# 218537
🇯🇵Kashiwa-shi, Chiba, Japan
National Cheng Kung University Hospital /ID# 222602
🇨🇳Tainan, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222603
🇨🇳Taoyuan City, Taiwan
Highlands Oncology Group, PA /ID# 215383
🇺🇸Springdale, Arkansas, United States
The Chaim Sheba Medical Center /ID# 217538
🇮🇱Ramat Gan, Tel-Aviv, Israel